Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)

Healthy

Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)

Berry extract

Placebo

The University of Nebraska at Omaha

Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults

Impacts of a Combined Berry Extract Supplement on Endothelial Function, Blood Pressure, Oxygen Utility Capacity, and Fatigue Index in Healthy Young Adults

Endothelial function was measured using flow-mediated dilation in percents (%). A higher value represents a better outcome. Scale range for endothelial function is approximately 8-12% for healthy populations.

Systolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129 for most healthy populations.

Diastolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 70-79 mmHg for most healthy populations.

Oxygen utility capacity was measured as tissue saturation index in percents (%). Higher values represent a better outcome. Scale range for tissue saturation index is approximately 70-100% for most healthy populations.

Song-Young Park

Assistant Professor

University of Nebraska, Omaha

Randomized, placebo-controlled, crossover design (1:1)

Neither the subject nor the investigators were aware of the study assignments, which were assigned by a lab member not directly involved in the measurements of the research.

Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.

Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo.

Recurrent Prostate Cancer

The patients will take 4 capsules by mouth BID (twice daily).

Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.

WG Hefner VA Medical Center

Wake Forest Baptist Medical Center

Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: <50 normal; 50-59 mild; 60-69 moderate; ≥70 severe.

General Quality of Life will be measured using the Patient Reported Outcomes Measurement Information System© (PROMIS©) Global Health Short Form (SF), a 10-item instrument representing multiple domains. Items assess self-reported measures of general aspects of physical, mental and social health in adults. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better general health than the general population.

Quality of life will be assessed by the Hot Flash Related Daily Interference Scale (HFRDIS). HFRDIS is a 10-item scale that assesses the degree to which hot flashes interfere with a variety of daily activities and quality of life. Interference is rated on an 11-point scale (0=not interfere; 10=completely interfere). Higher scores indicate more interference.

Sleep disturbance will be measured using the PROMIS Sleep Disturbance (SD) SF 8a. The PROMIS-SD items assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each question has five response options ranging in value from one to five. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted to a standardized T-score. Higher scores indicate more sleep disturbance.

Cognitive abilities will be measured using the PROMIS Cognitive Abilities SF 4a, which assesses patient-perceived functional abilities related to mental acuity, concentration, and memory. Raw scores are converted to a standardized T-score; final scores are represented by the T-score. Higher scored indicate more cognitive ability.

Self-reported physical function will be measured using the PROMIS Physical Function 10a SF, which is designed to assess self-reported capability rather than actual performance of physical activities. The form consists of 10 items. Raw scores are summed within each sub-domain, and converted to T-scores. Higher scores indicate better physical function general health than the general population.

Physical performance will be objectively assessed using the Short Physical Performance Battery (SPPB). Each performance measure is scored ranging from 0-4 (0 = unable to complete; 4 = highest performance level), with total sum score range from 0-12. Lower score on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.

Submaximal (6-minute walk) exercise capacity will be measured to assess physical fitness.

Whole body lean mass, fat mass, and bone mass will be measured by duel energy X-ray absorptiometry (DXA). BMI will be calculated from height and weight.

PSA will be measured at baseline, 6, and 12 months while patient is on MGE/placebo.

Progression-free survival is defined as the time from initiation of ADT treatment to disease progression or death.

Wake Forest University Health Sciences

This is a double-blind study. Only the lead-site investigational pharmacy team and the statistician will unblinded. The blind will be maintained until the study is complete.

anthocyanin/fatigue

Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults

Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

Шинжлэх ухаанаар баталгаажсан эмийн өвс ургамлын бүрэн мэдээллийн сан